NextBillion - An Initiative of the William Davidson Institute at the University of Michigan

Thursday, February 26, 2015

The first clinical safety trial on a tuberculosis drug since 2009 is now under way.

The phase I trial of TBA-354 will involve 50 volunteers from the United States, according to the TB Alliance, the not-for-profit product development partnership sponsoring the trial.

In preclinical studies, the compound showed more potent antibacterial and sterilising activity than pretomanid (PA-824), a related substance now in phase II and phase III clinical trials to assess its safety and efficacy, the alliance announced last week.

It said that the six years that passed between TBA-354 and the last drug to undergo Phase 1 trials shows that the pipeline of drugs to combat tuberculosis is disconcertingly empty.

Several promising TB medicines have reached phase II and phase III trials, but a more robust pipeline is needed to protect against drug resistance and reduce the time patients need for treatment, which at present ranges from six months to two years, the alliance said.

“While there has been considerable progress in pursuit of new TB drugs over the last decade, the global pipeline is still relatively small in comparison to what is needed to truly revolutionise TB treatment,” says Stephen Murray, the alliance’s senior medical officer. “While there are multiple products in late stage clinical trials, the risk of those products not making it to registration is a reality of drug development, and we must protect against that risk.”